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Completed

NCT Number: NCT02062281

Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults

The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs), meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children and adults. The main objective of this study is to show that both vaccines can safely be administered together without affecting the immune response of protecting against disease.

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Key information

Age range

3 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yangzhong Center for Disease Control and Prevention

Zhenjiang, Jiangsu, 212200, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy male or female, for adults 50-65 years of age, for children 3-7 years of age.
  • Available for the duration of the trial - approximately 2 months.
  • No history of severe adverse reaction associated with a vaccine.

Exclusion criteria

  • Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc.
  • Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
  • Autoimmune disease or immunodeficiency.
  • Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids.
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes History of thyroidectomy or thyroid disease that required medication within the past 12 months.
  • Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
  • Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
  • Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
  • History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing.
  • Administration of any other investigational research agents within 30 days before the dosing.
  • Administration of any live attenuated vaccine within 30 days before the dosing Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing.
  • Axillary temperature > 37.0 centigrade at the time of dosing.
  • Psychiatric condition that precludes compliance with the protocol.
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Treatment and study plan

23-valent pneumococcal polysaccharide vaccine

Biological

Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)

Trivalent Influenza Vaccine

Biological

Single 0.5ml trivalent influenza vaccine was administered IM

23vPPV+TIV

Biological

Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.

Primary outcomes

  1. Immunogenicity of 23vPPV

    Time frame: 1 month after 23vPPV vaccination

    IgG GMC measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1,2,5,6B,14,19F,23F,which were frequently detected in patients in Chinese.

  2. Immunogenicity of TIV

    Time frame: 1 month after TIV vaccination

    Percentage of participants achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)

Secondary outcomes

  1. adverse events following the immunization (AEFI)

    Time frame: 28 days after 23vPPV and TIV vaccination

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Collaborators

  • Chengdu Institute of Biological Products Co.,Ltd.
  • Shanghai Institute Of Biological Products

Registry information

Official study title

A Phase 4, Randomized, Single-blind Trial to Evaluate Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine When Administered Simultaneously With Trivalent Inactivated Influenza Vaccine in Healthy Children Aged 3-7years and Healthy Adults 65 Aged 50-65years.

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 13, 2014
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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